MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number	3241
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a brake malfunction occurred.The severely calcified target lesion was located in the coronary artery.A 2.25mm rotalink plus was selected for use.During the procedure, it was noted that the brake defeat button of the rotablator was not pressed; however, the wire came off.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that a brake malfunction occurred.The severely calcified target lesion was located in the coronary artery.A 2.25mm rotalink plus was selected for use.During the procedure, it was noted that the brake defeat button of the rotablator was not pressed; however, the wire came off.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the advancer, handshake connections, sheath, coil and burr were microscopically and visually examined.Numerous kinks were noted on the sheath.Functional testing was done using a test rotawire which was inserted into the device and was clipped in place using a test wire clip.The advancer was connected to the rotablator control console system to perform the brake test.There were no abnormal noises or leaks and the device did not run and was not able to get any speed.The advancer was dismantled and the ultem was observed to be melted and the turbine was corroded.There was no visible damage to the brake.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: ROTALINK PLUS
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8424611
• Report Number: 2134265-2019-02479
• Device Sequence Number: 13902266
• Product Code: MCX
• UDI-Device Identifier: 08714729228394
• UDI-Public: 08714729228394
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2020
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 22779913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1